Efficacy Study on Trabectedin in Retroperitoneal Leiomyosarcoma and Well Differentiated/Dedifferentiated Liposarcoma

• Status: Completed
• Trial end date: 2019-03-12
• Target enrollment: 0
• Participant gender: All

Summary

This is an Italian, multicentre, single arm, phase II study, with an intra-patient comparison end point. This study aims at confirming the activity of the drug trabectedin as second/further line treatment in retroperitoneal leiomyosarcoma and well differentiated/dedifferentiated liposarcoma expressed in terms of slowing down tumour growth.

Another objective is to investigate this peculiar benefit of trabectedin in typical retroperitoneal sarcomas may be exploited to help multidisciplinary clinical decision-making in the management of retroperitoneal sarcomas

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italian Sarcoma Group
• Collaborator: Istituto Di Ricerche Farmacologiche Mario Negri
• Treatments: Trabectedin

Criteria

Inclusion Criteria:

• Persistent or locally relapsed and/or metastatic disease (in case of local disease, surgery may be technically feasible or not, but the clinical judgment must be that medical therapy is indicated)

• Pathology specimens available for centralized review

• Age ≥ 18 years

• European Eastern Cooperative Oncology Group Personal Status (ECOG PS) ≤ 2

• One or more previous systemic treatments employing anthracyclines and ifosfamide (unless one or both are clinically contraindicated)

• Measurable disease, as defined by Response Evaluation Criteria In Solid Tumors (RECIST)

• A minimum of 3 weeks since any previous medical therapy

• Recovery from toxic effects of prior therapies to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 1 or lower

• Adequate haematological, renal and liver functions

• Ability and willingness to provide informed consent

Exclusion Criteria:

• Pregnant or breast-feeding women

• Prior exposure to trabectedin

• Peripheral neuropathy, Grade 2 or higher

• History of other malignancies (except for basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission for 5 years or more and judged of negligible potential of relapse

• Known central nervous system (CNS) metastases

• Active viral hepatitis or chronic liver disease

• Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias

• Active major infection

• Other serious concomitant illnesses